CAFE:Cancer Patient Fracture Evaluation Study

The Cancer Patient Fracture Evaluation (CAFE) study is the first randomized controlled trial comparing BKP with NSM for the treatment of Vertebral Compression Fractures (VCFs) in cancer patients.

In a prospective RCT involving 134 cancer patients (including multiple myeloma, breast, lung, and prostate cancers) those who received a BKP experienced rapid pain relief with significantly better results at 1 week and sustained pain relief at 1 month vs. the control group (p>.0001). In the same trial, nearly 65% or 38 out of 52 patients in the nonsurgical management group opted to undergo BKP at the 1 month follow up.

Lowering the need for pain medications in cancer patients can decrease the risk of drug related side effects and poor tolerability. Improving patient function reduces the risk of complications related to be bedridden, including deep vein thrombosis and pneumonia (Berenson et al, CAFE Study 2011).

Improved Quality of Life

Kyphon® Balloon Kyphoplasty patients required fewer pain medications, walking aids, braces and had fewer days of reduced activity and bed rest than patients treated with non-surgical management at one month.

More BKP patients were more independent one month after the procedure.

Comparable Safety Results vs. NSM

BKP was found to be safe for treating VCFs in patients with cancer. The number of patients with medical adverse events was similar between BKP and NSM groups from baseline to a 10month period, as randomized. Two patients in this timeframe had serious adverse events considered device/procedure related that were resolved.

Authors concluded that BKP, a percutaneous procedure, "typically requires minimal recovery time and does not delay chemotherapy or radiation therapy."

Background: Non-randomized trials have reported benefits for kyphoplasty in patients with cancer and vertebral compression fractures (VCFs). We aimed to assess the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful VCFs.

Methods: The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Europe, the USA, Canada, and Australia. We enrolled patients aged at least 21 years who had cancer and one to three painful VCFs. Patients were randomly assigned by a computer-generated minimisation randomisation algorithm to kyphoplasty or non-surgical management (control group). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analysed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the control group were allowed to cross-over to receive kyphoplasty after 1 month. This study is registered with ClinicalTrials.gov, NCT00211237.

Findings: Between May 16, 2005, and March 11, 2008, 134 patients were enrolled and randomly assigned to kyphoplasty (n=70) or non-surgical management (n=64). 65 patients in the kyphoplasty group and 52 in the control group had data available at 1 month. The mean RDQ score in the kyphoplasty group changed from 17.6 at baseline to 9.1 at 1 month (mean change -8.3 points, 95% CI -6.4 to -10.2; p<0.0001). The mean score in the control group changed from 18.2 to 18.0 (mean change 0.1 points; 95% CI -0.8 to 1.0; p=0.83). At 1 month, the kyphoplasty treatment effect for RDQ was -8.4 points (95% CI -7.6 to -9.2; p<0.0001). The most common adverse events within the first month were back pain (four of 70 in the kyphoplasty group and five of 64 in the control group) and symptomatic vertebral fracture (two and three, respectively). One patient in the kyphoplasty group had an intraoperative non-Q-wave myocardial infarction, which resolved and was attributed to anesthesia. Another patient in this group had a new VCF, which was thought to be device related.

Interpretation: For painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function.

IMPORTANT SAFETY INFORMATION

The complication rate with Kyphon® Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.

Results may vary. Keep in mind that all treatment and outcome results are specific to the individual patient. Please consult your physician for a complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.